The knee joint provides six degrees of motion during dynamic activities. One such activity is deep flexion or bending of the knee joint. The six degrees of motion are effected by complex movements or kinematics of the bones and soft tissue in the knee joint. Most individuals are capable of controlling the complex movement of a knee joint without thought. The absence of conscious control belies the intricate interactions between a number of different components which are necessary to effect activities such as flexion and extension (when the leg is straightened) of a knee joint.
The knee joint includes the bone interface of the distal end of the femur and the proximal end of the tibia. The patella is positioned over the distal end of the femur and is positioned within the tendon of the long muscle (quadriceps) on the front of the thigh. This tendon inserts into the tibial tuberosity and the posterior surface of the patella is smooth and glides over the femur.
The femur is configured with two large eminences (the medial condyle and the lateral condyle) which are substantially smooth and articulate with the medial plateau and the lateral plateau of the tibia, respectively. The plateaus of the tibia are substantially smooth and slightly cupped thereby providing a slight receptacle for receipt of the femoral condyles. The complex interactions of the femur, the tibia and the patella are constrained by the geometry of the bony structures of the knee joint, the menisci, the muscular attachments via tendons, and the ligaments. The ligaments of the knee joint include the patellar ligament, the medial and lateral collateral ligaments, the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL). The kinematics of the knee are further influenced by synovial fluid which lubricates the joint.
A number of studies have been directed to understanding the manner in which the various knee components interact as a knee joint moves through flexion. One such study was reported in an article by P. Johal, et al. entitled “Tibio-femoral movement in the living knee. A study of weight bearing and non-weight bearing knee kinematics using ‘interventional’ MRI, Journal of Biomechanics, Volume 38, Issue 2, February 2005, pages 269-276, which includes a FIG. 2 from which the data set forth in FIG. 1 as graph 10 has been derived. The graph 10 shows the locations of the medial and lateral condyle reference points of a native knee with respect to a tibia as the knee moves through flexion. The line 12 of the graph 10 indicates that the lateral condyle exhibits a constant anterior to posterior translation through deep flexion while the line 14 indicates that the medial condyle remains at about the same location on the tibial plateau until about 90 degrees of flexion. Beyond 90 degrees of flexion, the medial condyle exhibits anterior to posterior translation.
The medial and lateral condyle low (tangency) points are not the actual contact points between the condyles and the femoral plane. Rather, the points represent the lowest portion of the condyle that can be viewed using fluoroscopy. The actual contact point is generally at a location more posterior to the low (tangency) points. Nonetheless, the use of low (tangency) points provides a valid basis for comparison of the effect of changing design variables between components.
Damage or disease can deteriorate the bones, articular cartilage and ligaments of the knee. Such changes from the normal condition of the knee joint can ultimately affect the ability of the natural knee to function properly leading to pain and reduced range of motion. To ameliorate the conditions resulting from deterioration of the knee joint, prosthetic knees have been developed that are mounted to prepared ends of the femur and tibia.
While damage to soft tissue is avoided to the extent possible during knee replacement procedures, some tissue is necessarily sacrificed in replacing a portion of the femur and tibia. Thus, while the typical individual has learned how to coordinate the tensioning of the muscle fibers, ligaments and tendons to provide a smooth transition from a present positioning of the knee to a desired positioning without conscious thought, the sacrifice of tissue changes the physics of the knee. Accordingly, the configuration of soft tissue used to cause movement such as flexion and extension in a healthy knee, or even a pre-operative knee, no longer achieves the same results when the knee is replaced with a prosthesis. Additionally, the sacrifice of soft tissue results in reduced stability of the knee joint.
To compensate for the loss of stability that results from the damage to soft tissue, four general types of implants have been developed. In one approach, the PCL is retained. When the PCL is retained, patients frequently encounter an unnatural (paradoxical) anterior translation of the contact point between the lateral condyle of the femur and the tibia during deep knee-bend movements. Rather than rolling back or slipping as a knee moves through flexion, the femur slides anteriorly along the tibial platform. Paradoxical anterior translation is typically initiated between 30 and 40 degrees of flexion although it can commence at up to about 120 degrees of flexion. The resulting loss of joint stability can accelerate wear, cause a sensation of instability during certain activities of daily living, result in abnormal knee joint motion (kinematics), and/or result in a reduced dynamic moment arm to the quadriceps requiring increased force to control movement.
By way of example, FIG. 2 depicts a sagittal view of a typical prior art femoral component 20 which attempts to mimic the shape of a native knee. The femoral component 20 includes an extension region 22 which is generally anterior to the line 24 and a flexion region 26 which is posterior to the line 24. The extension region 22 is formed with a large radius of curvature (Rc) 28 while a small Rc 30 is used in the posterior portion of the flexion region 26 in order to fit within the joint space while providing as much flexion as possible. Contemporaneously with the change of length of the radii of curvature, the origin of the radius of curvature changes from the origin 32 for the Rc 28 to the origin 34 for the Rc 30.
The results of a deep knee bending simulation using a typical prior art femoral component with condylar surfaces in the flexion area defined by a reduced radius of curvature are shown in the translation chart 40 of FIG. 3 which shows the position on the tibial component (y-axis) whereat the medial and lateral condyles contact the tibial component as the device is moved through flexion (x-axis). The simulation was conducted on a multibody dynamics program commercially available from Biomechanics Research Group, Inc. of San Clemente, Calif., under the name LifeMOD/KneeSIM. The model included tibio-femoral and patello-femoral contact, passive soft tissue, and active muscle elements.
The lines 42 and 44 in the chart 40 show the estimated low (tangency) points for the lateral condylar surface and the medial condylar surface, respectively. Both of the lines 42 and 44 initially track posteriorly (downwardly as viewed in FIG. 3) between 0 degrees and about 30 degrees of flexion. This indicates that the femoral component is rolling posteriorly on the tibial component as the flexion angle increases. Beyond about 30° of flexion, the estimated lateral condyle low (tangency) point line 42 drifts slightly anteriorly from about 5 mm translation while the estimated medial condylar low (tangency) point line 44 moves rapidly anteriorly. Movement of both surfaces in the anterior direction shows that paradoxical anterior translation is occurring beyond about 30 degrees. A comparison of the lines 42 and 44 beyond 30° of flexion with the lines 12 and 14 of FIG. 1 reveals a striking disparity in kinematics between the native knee and the replacement knee which mimics the geometry of the native knee.
Additionally, returning to FIG. 2, as the femoral component 20 is flexed such that contact with a tibial component (not shown) occurs along the condylar surface defined by the Rc 28, the forces exerted by soft-tissues on the knee are coordinated to provide a smooth movement based, in part, upon the length of the Rc 28 and the origin 32. As the femoral component 20 is moved through the angle at which the condylar surface transitions from the Rc 28 to the Rc 30, the knee may initially be controlled as if it will continue to move along the Rc 28. As the femoral component 20 continues to move, the actual configuration of the knee diverges from the configuration that would be achieved if the surface in contact with the tibial component (not shown) was still defined by the Rc 28. When the divergence is sensed, it is believed that the soft-tissue forces are rapidly re-configured to a configuration appropriate for movement along the surface defined by the Rc 30 with the origin 34. This sudden change in configuration, which is not believed to occur with a native knee, contributes to the sense of instability.
Furthermore, Andriacchi, T. P., The Effect of Knee Kinematics, Gait and Wear on the Short and Long-Term Outcomes of Primary Total Knee Replacement, NIH Consensus Development Conference on Total Knee Replacement, pages 61-62, (Dec. 8-10, 2003) reports that in a native knee, flexion between 0 and 120 degrees is accompanied by approximately 10 degrees of external rotation of the femur with respect to the tibia while an additional 20 degrees of external rotation is required for flexion from 120 degrees to 150 degrees. Thus, an initial ratio of about 0.008 degrees of external rotation per degree of flexion is exhibited between 0 degrees and 120 degrees of flexion which increases to a ratio of 0.67 degrees of external rotation per degree of flexion between 120 degrees and 150 degrees of flexion. This rotation allows the knee to move into deep flexion.
The reported external rotation of the native knee is supported by the data in FIG. 1. Specifically, between about 9 degrees and 90 degrees of flexion, the slope of the line 12 is constantly downward indicating that the lowest point of the lateral condylar surface is continuously tracking posteriorly. The line 14, however, is moving anteriorly from about 9 degrees of flexion through 90 degrees of flexion. Thus, assuming this difference to be solely due to external rotation, the femoral component is externally rotating as the knee moved from about 9 degrees of flexion to about 90 degrees of flexion. Beyond 90 degrees of flexion, the lines 12 and 14 show that both condylar surfaces are moving posteriorly. The lateral condylar surface, however, is moving more rapidly in the posterior direction. Accordingly, the gap between the lines 12 and 14 continues to expand beyond 90 degrees, indicating that additional external rotation of the knee is occurring.
FIG. 4 shows the internal rotation of the tibia with respect to the femur (which from a modeling perspective is the same as external rotation of the femur with respect to the tibia, both of which are identified herein as “φi-e”) during the testing that provided the results of FIG. 3. The graph 50 includes a line 52 which shows that as the tested component was manipulated to 130 degrees of flexion, the φi-e reached a maximum of about seven degrees. Between about 0 degrees of flexion and 20 degrees of flexion, the φi-e varies from 1 degree to zero degrees for a change rate of −0.05 degrees of internal rotation per degree of flexion. Between about 20 degrees of flexion and 50 degrees of flexion, the internal rotation varies from 0 degrees to 1 degree for a change rate of 0.03 degrees of internal rotation per degree of flexion. Between about 50 degrees and 130 degrees, the graph 50 exhibits a nearly linear increase in internal rotation from about 1 degree to about 7 degrees for a change rate of 0.075 degrees of internal rotation per degree of flexion. Accordingly, the φi-e of a knee joint incorporating the prior art femoral component differs significantly from the φi-e of a native knee.
Various attempts have been made to provide kinematics more akin to those of the native knee. For example, the problem of paradoxical anterior translation in one type of implant is addressed by sacrificing the PCL and relying upon articular geometry to provide stability. In another type of implant, the implant is constrained. That is, an actual linkage is used between the femoral and tibial components. In another type of implant, the PCL is replaced with a cam on the femoral component and a post on the tibial component. While the foregoing approaches have some effectiveness with respect to paradoxical anterior translation, they do not provide other kinematics exhibited by a native knee.
What is needed is a knee prosthesis that more closely reproduces the inherent stability and kinematics of a native knee such as by managing rotation and rollback.